510(k) K020575 ยท MRR System, Test, Low Density, Lipoprotein
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Apr 12, 2002 |
| Received | Feb 21, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020575
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.